N/A N=9 Other

SurgiMend Mesh at the Hiatus

Hiatal Hernia

Bottom Line

View on ClinicalTrials.gov: NCT04282720 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: Recurrence Rate — 6; 3 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SurgiMend Mesh (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Kettering Health Network
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Recurrence Rate	6; 3	—
SECONDARY Quality of Life Using GERD-HRQL Scale	15.67; 7.37; 15.44; 6.38; 35.44; 17.38	0.07

Summary

Prospective, single-arm, open-label study to evaluate re-occurrence and quality of life in subjects undergoing primary Hiatal hernia repair using SurgiMend biological mesh. Up to 15, with a target of 10, subjects are planned to be enrolled at one site. All subjects will receive the SurgiMend mesh during surgery. Data collected will be compared to historical data. Subjects will complete a pre-operative visit. After surgery, in addition to any standard of care visits, subjects will complete 3- and 6-month follow-ups involving a phone QOL survey and will have an upper GI series at 6 months.

Eligibility Criteria

Inclusion Criteria

Diagnosis of type 3 or 4 hiatal hernia (8)
Subject is able to give informed consent
Adults at least 18 years of age

Exclusion Criteria

Currently pregnant
Prior hiatal hernia repair
Prior gastric surgery
Prior foregut surgery
Known esophageal dysfunction or dysmotility
Cirrhosis or ascites
Known malignancy
Known allergy to biologic mesh
Known allergy to barium or other contrast material used in UGI
Religious objection to animal implant
Cognitive impairment
Prisoners

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04282720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.